Clotrimazole (topical Solution) Usp, 1%

Clotrimazole (topical Solution) Usp, 1%
SPL v15
SPL
SPL Set ID 5f8ca6ad-cb25-1abf-e053-2a91aa0aca99
Route
TOPICAL
Published
Effective Date 2017-12-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (1 g)
Inactive Ingredients
Polyethylene Glycol 400

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-12-08

Description

CLOTRIMAZOLE USP, 1%

Purpose

ANTIFUNGAL


Medication Information

Purpose

ANTIFUNGAL

Description

CLOTRIMAZOLE USP, 1%

Uses

Cures most

  • Athlete's foot (tinea pedis)
  • Jock Itch (tinea cruris)
  • Ringworm (tinea corporis)

Effectively relieves

  • itching
  • cracking
  • burning

Discomfort which can accompany these conditions

Warnings
  • For external use only

Ask a doctor before use

on children under 2 years of age

When using this product

avoid contact with eyes

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch)

Directions

This product is not effective on the scalp or nails. For best results, follow directions and continue treatment for length of time indicated. For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks.

  • clean the affected area and dry thoroughly
  • apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
  • supervise children in the use of this product.

For athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes; change shoes and socks at least once daily.

Questions?

please call 1-888-266-8818

Active Ingredient

CLOTRIMAZOLE USP, 1%

Other Information
  • Store at 15°to 30°C (59° to 86°F)

Inactive Ingredients

polyethylene glycol 400

Keep Out of Reach of Children

If swallowed, get medical help or contact a poison control center right away.

Principal Display Panel 10ml Bottle Carton

NDC 70795-8020-1

GRAXCELL PHARMACEUTICAL, LLC.

Compare to the active ingredient of Lotrimin®AF*

10ML Bottle

Clotrimazole (Topical Solution) USP,1%

Antifungal

Relieves Itching & Burning

  • Greaseless
  • Non-staining

For External use only.

Not for Opthalmic use.

Keep this and all medications out of the reach of children.


Structured Label Content

Uses (USES)

Cures most

  • Athlete's foot (tinea pedis)
  • Jock Itch (tinea cruris)
  • Ringworm (tinea corporis)

Effectively relieves

  • itching
  • cracking
  • burning

Discomfort which can accompany these conditions

Purpose (PURPOSE)

ANTIFUNGAL

Warnings (warnings)
  • For external use only

Ask a doctor before use

on children under 2 years of age

When using this product

avoid contact with eyes

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch)

Directions

This product is not effective on the scalp or nails. For best results, follow directions and continue treatment for length of time indicated. For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks.

  • clean the affected area and dry thoroughly
  • apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
  • supervise children in the use of this product.

For athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes; change shoes and socks at least once daily.

Questions? (questions?)

please call 1-888-266-8818

Active Ingredient (ACTIVE INGREDIENT)

CLOTRIMAZOLE USP, 1%

Other Information (other information)
  • Store at 15°to 30°C (59° to 86°F)

Inactive Ingredients (inactive ingredients)

polyethylene glycol 400

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

If swallowed, get medical help or contact a poison control center right away.

Principal Display Panel 10ml Bottle Carton (PRINCIPAL DISPLAY PANEL-10ML BOTTLE CARTON)

NDC 70795-8020-1

GRAXCELL PHARMACEUTICAL, LLC.

Compare to the active ingredient of Lotrimin®AF*

10ML Bottle

Clotrimazole (Topical Solution) USP,1%

Antifungal

Relieves Itching & Burning

  • Greaseless
  • Non-staining

For External use only.

Not for Opthalmic use.

Keep this and all medications out of the reach of children.


Advanced Ingredient Data


Raw Label Data

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